Angiex’s IND application for AGX101 cleared by FDA
Betsy Goodfellow | November 3, 2023 | News story | Medical Communications | AGX101, Angiex, FDA, Oncology
Angiex has announced that the US Food and Drug Administration has cleared its Investigational New Drug (IND) application for AGX101, a novel TM4SF1-directed antibody-drug conjugate (ADC) in development for the treatment of solid cancers.
The company focuses on the development of Nuclear-Delivered Antibody-Drug Conjugate (ND-ADC) therapies for the treatment of solid cancers.
Angiex will now begin enrolling patients to its phase 1 study which is an open-label, dose-escalation and expansion study to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumour activity of AGX101 as a monotherapy.
Marty Duvall, chief executive officer of Angiex, commented: “IND acceptance of AGX101 enables us to initiate our first-in-human study of AGX101 and brings us one step closer to validating AGX101 and demonstrating the value of Angiex’s paradigm-shifting ND-ADC approach to cancer therapy. We are thrilled to advance the development of AGX101 and begin enrolling patients in the phase 1 study.”
Paul Jaminet, founder, president and chief operating officer of Angiex, added: “TM4SF1 is an emerging cancer target with exciting features: dual expression on tumour cells and tumour vascular endothelial cells, almost ubiquitous expression across solid tumours, but limited expression in normal tissue, providing for exceptional tumour selectivity. Angiex also is pioneering a novel ability to release ADC payloads in the nucleus of target cells in the tumour. AGX101 is a highly optimised drug based on years of biology research and drug development. Its strong pre-clinical evidence supports its potential to provide transformative outcomes for cancer patients.”
Betsy Goodfellow
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